Question 1

What types of medical devices does Medical Wire & Equipment Co Bath (Ltd) manufacture?

Accepted Answer

Medical Wire & Equipment Co Bath (Ltd) specializes in swab collection devices for clinical and laboratory use. Their portfolio includes dry fecal swabs (like the U-SWAB™ FECAL DRY), viral transport swabs, and swabs for collecting and transporting specimens such as nasopharyngeal, oropharyngeal, and rectal samples. These devices are designed for diagnostic, screening, and monitoring purposes in healthcare settings, supporting both infectious disease testing and general specimen collection.

Question 2

Where is Medical Wire & Equipment Co Bath (Ltd) based?

Accepted Answer

The company is based in the United Kingdom, specifically in Bath. This location places it within the European Economic Area, where it operates under the regulatory framework for medical devices and in vitro diagnostics (IVDs) applicable to the region.

Question 3

Which regulatory registries list the devices produced by Medical Wire & Equipment Co Bath (Ltd)?

Accepted Answer

The company’s devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This platform is used to track and provide transparency on medical devices and IVDs authorized within the European Economic Area, ensuring compliance with EU Medical Device Regulations.

Question 4

How are the devices manufactured by Medical Wire & Equipment Co Bath (Ltd) classified under EU regulations?

Accepted Answer

The company’s devices fall under various classification categories within the EU Medical Device Regulations, including Class A, Class I, Class IIa, and In Vitro Diagnostic (IVD) General. The classification depends on factors like the intended use, risk level, and the type of specimen collection or diagnostic purpose, ensuring appropriate regulatory oversight and compliance.

Device	Model / Reference	Registries	Class	Status
Sigma Swab	MW940	EUDAMEDFDA UDI	Class I	Active
Sigma Virocult	MW950T	EUDAMED	IVD General	Active
Wire microloop	MW186	EUDAMED	Class A	Active
Dryswab	MW1048	EUDAMEDFDA UDI	Class I	Active
Sigma Transwab	501006	EUDAMEDFDA UDI	Class I	Active
Transtube	MW167	EUDAMED	Class IIa	Active
Microloop	MW71020	EUDAMED	IVD General	Active
Sigma Transwab	MW177S	EUDAMEDFDA UDI	Class I	Active
Microloop	MW71120	EUDAMED	IVD General	Active
Transwab	MW171	EUDAMEDFDA UDI	Class IIa	Active
Sigma VCM	MW926T	EUDAMED	IVD General	Active
Sigma Transwab	MW178PF	EUDAMED	Class I	Active
Dryswab	MW112BP	EUDAMEDFDA UDI	Class I	Active
Dryswab	325005	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW1048J	EUDAMEDFDA UDI	Class I	Active
Dryswab	Mw112/2	EUDAMEDFDA UDI	Class I	Active
Dryswab	325004	EUDAMEDFDA UDI	Class I	Active
Sigma TSB	MWTSB65R	EUDAMED	Class I	Active
Sigma TSB	MWTSB65T	EUDAMED	IVD General	Active
Transwab	MW166P	EUDAMEDFDA UDI	Class IIa	Active
Microloop	MW70520	EUDAMED	IVD General	Active
Sigma Virocult	MW951T3	EUDAMED	IVD General	Active
Sigma VCM	MW910S	EUDAMED	Class I	Active
Sigma GBS	MWGBS	EUDAMED	Class I	Active
U-Swab	M200141	EUDAMED	Class I	Active
Transwab	MW169C	EUDAMEDFDA UDI	Class IIa	Active
Sigma VCM	501706	EUDAMED	Class I	Active
Transwab	MW172P	EUDAMEDFDA UDI	Class I	Active
Sigma VCM	501702	EUDAMED	Class I	Active
Dryswab	MW112	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW160	EUDAMEDFDA UDI	Class I	Active
Transwab	MW175C	EUDAMEDFDA UDI	Class IIa	Active
Sigma VCM	MW911PF3ML	EUDAMED	Class I	Active
U Swab	M200142	EUDAMED	Class I	Active
Dryswab	MW811	EUDAMED	Class I	Active
Transwab	MW173C	EUDAMEDFDA UDI	Class I	Active
Sigma VCM	Sigma VCM™	EUDAMED	Class I	Active
Sigma Virocult	MW951T15	EUDAMED	IVD General	Active
Sigma Virocult	MW951SENT2ML	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW832	EUDAMED	Class I	Active
Sigma Virocult	MW950S	EUDAMEDFDA UDI	Class I	Active
Sigma TSB	MWTSB65	EUDAMED	Class I	Active
Sigma VCM	501701	EUDAMED	Class I	Active
Dryswab	MW151	EUDAMED	Class I	Active
Wire microloop	MW1951	EUDAMED	Class A	Active
Sigma Transwab	MW177PF	EUDAMED	Class I	Active
Sigma Virocult	M400001	EUDAMEDFDA UDI	Class I	Active
Sigma Swab	MW940/79	EUDAMED	Class I	Active
Transwab	MW171SH	EUDAMED	Class I	Active
Sigma Transwab	MW176S3ML	EUDAMEDFDA UDI	Class IIa	Active

Medical Wire & Equipment Co Bath (Ltd)

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